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Effect of Empagliflozin on Inflammation

NCT07292909 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-18

No results posted yet for this study

Summary

Empagliflozin is a drug given to lower glucose. It is used in the treatment of diabetes. However, it was shown to improve symptoms and survival of patients who are suffering from heart failure. The exact mechanism of this effect is currently not clearly understood.

He hypothesize that empagliflozin has other properties than glucose lowering, that can explain its efficacy. One of these properties, is an anti-inflammatory effect.

To document this, we are using a model of inflammation following percutaneous coronary scenting. We know that patients who get a stent will develop inflammation following stenting. This is documenting by a higher level of C-Reactive Protein 24 hours after the procedure.

Patients who will participate in the study, will receive empagliflozin or a placebo tablet for 3 days prior to the revascularisation procedure. CRP and other inflammatory markers will be measured before intervention and 24 hours later. The goal is to demonstrate a lower rise in CRP following intervention in patients treated with empagliflozin vs. those who have received a placebo.

Conditions

  • CAD - Coronary Artery Disease
  • Inflamation
  • PCI
  • SGLT 2 Inhibitors

Interventions

DRUG

Empagliflozin (SGLT2i)

Patient will receive 10 mg of empagliflozin PO per day, starting at least 2 days before planned PCI and on the day of PCI. Patient will thus receive at least 3 doses of empagliflozin prior to intervention

DRUG

Placebo

Patient will receive a matching placebo PO 1 tab per day, starting at least 2 days before planned PCI and on the day of PCI. Patient will thus receive at least 3 doses of empagliflozin prior to intervention

Sponsors & Collaborators

  • Hotel Dieu de France Hospital

    lead OTHER

Principal Investigators

  • Rabih R Azar, MD, MPH · Hotel Dieu de Frace

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • Lebanon

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292909 on ClinicalTrials.gov